Gaithersburg biotechnology company Digene Corp. said losses grew slightly in its fiscal second quarter as spending on patent litigation and European marketing offset higher sales of its flagship disease test.
Digene, which makes a test for the human papillomavirus (HPV), a common sexually transmitted disease known to cause cervical cancer, said its net loss in the quarter ended Dec. 31 grew to $1.3 million (7 cents per share), from $1.1 million (6 cents) in the year-earlier period.
The Food and Drug Administration has approved Digene's HPV test as a follow-up exam when results of Pap smears, the usual test for cervical cancer, are inconclusive. But the company predicted yesterday that the agency will approve the product as a primary screening test by the end of next month.
"We have every reason to believe that we submitted an excellent application and that the FDA will approve our product for this expanded use," said Charles M. Fleischman, Digene's president, chief operating officer and chief financial officer.
Four months ago, the company asked the agency to permit use of its Hybrid Capture 2 HPV Test in combination with the traditional Pap test in women 30 and older. Fleischman said he believes the market for such a test is at least $300 million a year. Cervical cancer, the second most common cancer among women, kills about 4,500 women a year, the company said.
An editorial in yesterday's edition of the New England Journal of Medicine said the technology that underpins Digene's HPV test "will probably receive approval" from the FDA for use alongside the Pap test.
Sales of Digene's HPV test rose nearly 25 percent in the quarter, driving up revenue to $14.5 million, from $11.6 million in the year-earlier quarter.
Digene said it was forced to spend heavily to resolve patent lawsuits with rivals Enzo Biochem Inc. and Ventana Medical Systems Inc. and to establish a sales and distribution system in Europe. Those costs, Fleischman said, accounted for the bulk of the company's quarterly loss.
Yesterday, Digene shares rose 49 cents, nearly 4 percent, to $14.15.